Towards Crowd-Based Needfinding in Medical Device Development1

Abstract

Public and private institutions invest over $100 billion annually in biomedical research [1]. These funds can be misused and the value diminished if the engineers and clinicians are not aligning work with areas of clinical need [2]. As medical device developers have pointed out, “Get (the clinical need) right and you have a chance, get it wrong and all further effort is likely to be wasted” [3, p. 3]. Needfinding is a formal tool within the design cycle used to fully understand the problem, particularly when involving human behavior [4]. While effective when used, these methods are reported to be underutilized in healthcare practice [5–7] due to unique challenges in healthcare [8,9]. This lack of early stage input can lead to unnecessary investment in new projects already destined to fall short of the potential clinical improvements motivating the work. The results reported here represent a preliminary feasibility study on a crowd-based method of needfinding. The long-term objective is to collect a broad, unfiltered list of potential unmet clinical needs from the point-of-view of technology users. This method can compliment data from existing observation-based methods currently used [3,4], but will have several advantages over existing methods, including: needs can be collected from a wider, more diverse sample of a surgeon population; individual time commitments can be minimized relative to in-depth interviews and observations; and the same data collection infrastructure can be leveraged to later prioritize unmet needs through formalized review and input from clinicians and professional medical societies. The study is designed to test the effectiveness of methods to overcome existing limitations of nonobservation-based interactions with users. Specifically, users are often unable to directly articulate how a technology fails to meet their needs because they have adapted to shortcomings and rarely consciously think of them [3].